Effect of a novel plant extract on the severity and duration of infectious diarrhoea in children and adults
| ISRCTN | ISRCTN11621877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11621877 |
| Secondary identifying numbers | PR-11036 |
- Submission date
- 09/01/2015
- Registration date
- 21/01/2015
- Last edited
- 05/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Infectious diarrhoea is a major threat to human health and treatment with antibiotics has led to resistant bacteria. Prevention and management of dehydration is standard care but does not reduce the duration of diarrhoea. The aim in this study is to assess the usefulness of a plant extract (LiveXtract) in reducing the duration of diarrhoea in children and adults.
Who can participate?
Male patients, age 6 months old to 60 years old, presenting with acute diarrhoea
What does the study involve?
Patients will be randomly allocated to one of two groups: LiveXtract mixed with ORS or water mixed with ORS. They will be monitored for up to 4 days.
What are the possible benefits and risks of participating?
A benefit is the reduction in the duration of diarrhoea. A risk might be a reaction to the LiveXtract solution.
Where is the study run from?
Dhaka Hospital (Bangladesh)
When is the study starting and how long is it expected to run for?
From July 2011 to October 2017
Who is funding the study?
LiveLeaf Inc (USA)
Who is the main contact?
Dr Thomas Lawson
tlawson@liveleaf.com
Contact information
Scientific
1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
 ORCID ID |
0000-0001-5182-4681 |
|---|---|
| Phone | +16505177288 |
| tlawson@liveleaf.com |
Study information
| Study design | Interventional randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Assessment of the therapeutic effect of LiveXtract, a novel plant extract, on the severity and duration of infectious diarrhoea in children and adults: a randomised double-blind placebo-controlled study |
| Study objectives | Use of the LiveXtract mixed with oral rehydration solution (ORS) will reduce the duration of diarrhoea compared with ORS alone. |
| Ethics approval(s) | ICDDR,B Ethical Review Committee, 29/12/2011, PR-11036 |
| Health condition(s) or problem(s) studied | Diarrhoea |
| Intervention | 1. LiveXtract solution mixed with ORS 2. Water mixed with ORS |
| Intervention type | Supplement |
| Primary outcome measure | Reduction in the severity and duration of diarrhoea, measured as the time the stool is ranked as a 4 or less on the Bristol Stool Scale |
| Secondary outcome measures | 1. Volume of ORS consumed from the time of randomisation to resolution of diarrhoea 2. Number of events and duration of emesis These outcomes will be monitored every 6 hours for 4 days and ranked with a Visual Analogue Scale of 0 to 10. |
| Overall study start date | 04/07/2011 |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Male |
| Target number of participants | The target total recruitment of participants is 736 patients. |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. Age 6 months old to 60 years old 2. Acute watery diarrhoea (for 48 hours or less) |
| Key exclusion criteria | 1. Fever 2. Bloody stool with or without abdominal pain 3. Clinical signs of coexisting severe acute systemic illness 4. Underlying severe chronic disease 5. Severe malnutrition 6. Signs of internal bleeding or black stools 7. Signs of drug abuse 8. Food allergy or other chronic gastrointestinal disease 9. Use of antibiotics or any anti-diarrhoeal medication during the previous 2 weeks 10. Any condition that the admitting physician believes will place the patient at risk if enrolled in the study 11. Participants whose stool cultures show Shigella spp 12. Unable or unwilling to provide informed consent |
| Date of first enrolment | 10/05/2012 |
| Date of final enrolment | 01/10/2017 |
Locations
Countries of recruitment
- Bangladesh
Study participating centre
Dahaka
1212
Bangladesh
Sponsor information
Industry
1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
| Phone | +16505177288 |
|---|---|
| tlawson@liveleaf.com | |
| Website | http://liveleaf.com |
"ROR" |
https://ror.org/00m48tn76 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/04/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This study is running in two phases: a pilot study for safety data, with submission of the results before April 2015; the second phase will begin in the summer of 2015 and is likely to last 18 months and these data will be submitted to a peer-reviewed journal before the end of 2016. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2015 | 05/03/2019 | Yes | No |
Editorial Notes
05/03/2019: Publication reference added.
